Insulin-like growth factor-I (
IGF-I) is an important
growth factor associated with increased risk of premenopausal
breast cancer. We conducted a randomized, placebo-controlled, double-blind, crossover trial to evaluate whether tomato-derived
lycopene supplementation (30 mg/day for 2 mo) decreases serum levels of total
IGF-I in premenopausal women with 1) a history of
breast cancer (n=24) or 2) a high
familial breast cancer risk (n=36). Also,
IGF binding protein (
IGFBP) increasing effects were evaluated.
Lycopene supplementation did not significantly alter serum total
IGF-I and other IGF system components in the 2 study populations combined. However, statistically significant discordant results were observed between the 2 study populations (i.e., P<0.05 for total
IGF-I, free
IGF-I, and
IGFBP-3). Total
IGF-I and
IGFBP-3 were increased in the
breast cancer survivor population [total
IGF-I=7.0%, 95% confidence interval (CI)= -0.2 to 14.3%;
IGFBP-3=3.3%, 95% CI=0.7-6.0%), and free
IGF-I was decreased in the family history population (-7.6%, 95% CI= -14.6 to -0.6%). This randomized controlled trial shows that 2 mo of
lycopene supplementation has no effect on serum total
IGF-I in the overall study population. However,
lycopene effects were discordant between the 2 study populations showing beneficial effects in high-risk healthy women but not in
breast cancer survivors.